A class action Valsartan lawsuit has been filed against a number of drugmakers over allegations that the medication poses a cancer risk. This is only the most recent of a growing number of lawsuits against drug manufacturers in the U.S., China and India, whom plaintiffs say fraudulently concealed information about Valsartan contamination with an industrial chemical known to be carcinogenic.

Although none of the plaintiffs has yet been diagnosed with cancer, they claim that they will require medical monitoring for the remainder of their lives.

About Valsartan

Valsartan is part of a class of drugs known as angiotensin II receptor blockers, or ARBs, sometimes called “sartan” drugs. These medications work by disabling the action of the hormone angiotensin, which normally cause the constriction of muscles surrounding the blood vessels.

Although the research behind ARBs dates back over 120 years, the first such medication was not available until the FDA approval of losartan in 1995. Today, there are a total six different medications of the ARB class containing sartan. Of those six, three – valsartan, irbesartan and losartan – have been affected by the risk of contamination.

Valsartan Lawsuit Cause of Action

The carcinogenic contaminants discovered in ARB medications are part of a family of industrial chemicals known as nitrosamines. The specific nitrosamines found in valsartan and similar drugs are N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Nitrosamines are found in trace amounts in smoked and cured meats, and they are also present in tobacco smoke. These chemicals are used in aviation fuel and industrial lubricants as well.

It is not known exactly how valsartan came to be contaminated. However, an investigation of facilities operated by Zhejiang Huahai Pharmaceuticals (one of the named defendants in the above-mentioned lawsuit) found that changes made in the manufacturing process may have accidentally triggered a chemical reaction, resulting in the nitrosamine formation.

Another source of contamination was Hetero Labs based in Hyderabad, India (also a named defendant). In 2017, the U.S. Food and Drug Administration issued a warning letter to Hetero Labs because of failure to adequately monitor its manufacturing process and ensure consistent drug quality.

Yet another Indian company that has been implicated in nitrosamine contamination is Mylan; in November, 2018, the European Medicines Agency (the E.U. counterpart to the F.D.A.) issued an order prohibiting the use of all valsartan originating from Mylan’s India operations.

What is the Valsartan Danger?

It should be noted that the nitrosamine levels detected in valsartan and other ARB medications is quite low. So far, there have been no cancer diagnoses that are directly attributable to valsartan. However, medical scientists believe any level of exposure to carcinogens such as NDMA and NDEA is dangerous. For those concerned, the FDA also released a list of uncontaminated drugs.

According to the valsartan lawsuit, exposure to high levels of NDMA has been linked to liver damage in humans. While one-time exposure to these chemicals may not result in cancer, long-term exposure over a period of months or years could cause the formation of malignant tumors.

If you have been taking valsartan for any length of time, with one of the recalled valsartan medications, you may have grounds for a valsartan lawsuit, In the meantime however, the FDA says it is inadvisable to discontinue taking a medication without consulting with your physician first. If you have cancer concerns about taking valsartan, check with your doctor first; you may be able to take an alternative medication for your condition.